Systems and methods for performing an intraocular procedure for treating an eye condition

ABSTRACT

The invention provides an excimer laser system including a means for calibrating laser output to compensate for increased variation in laser optical fibers.

RELATED APPLICATIONS

This application is a continuation patent application of U.S.Application No. 17/400,191, filed Aug. 12, 2021, which is a continuationpatent application of U.S. Application No. 16/389,359, filed Apr. 19,2019, now U.S. Pat. No. 11,103,382, all of which are incorporated hereinby reference in their entireties.

TECHNICAL FIELD

The disclosure relates to medical devices, and, more particularly, to anexcimer laser system including a means for calibrating laser output tocompensate for increased variation in laser optical fibers.

BACKGROUND

In the medical industry, there are many surgical devices, instruments,and systems comprised of individual components that must work togetherproperly to ensure treatment is performed safely and effectively. It iscritical that any given component falls within an acceptable toleranceto ensure that the component physically fits and interacts appropriatelywith other components and functions as intended.

The actual production of any product (or operation of any system)involves some inherent variation of input and output. Measurement errorand statistical uncertainty are also present in all measurements.Accordingly, tolerance is an inherent aspect when designing a device,instrument, or system. The concept of tolerance, sometimes referred toas engineering tolerance, relates to the permissible limit or limits ofvariation in a physical dimension of the component, a measured value orphysical property of the component, spacing between the component andanother component, and the like. Accordingly, if a component fallsoutside of a permissible tolerance (i.e., the component is too small,too large, fails to have acceptable properties, etc.), then the overalldevice, instrument, or system will fail to perform as designed.

One example of a surgical system composed of multiple components is amedical laser system. The medical laser system generally consists of alaser unit and a separate laser probe having an optical fiber fordirecting laser radiation from the laser unit to a treatment area. Laserunits provide laser light at specific wavelengths and, as a result, maybe designed to perform specific procedures. For example, certainprocedures may require photocoagulation of a target tissue, which occursupon delivery of laser radiation at a first wavelength, while otherprocedures may require photoablation of a target tissue, which occursupon delivery of laser radiation at a second wavelength. In turn,optical fibers to be used with these laser systems may have specificdimensions, material compositions, and/or functional properties (i.e.,operation at specific temperatures and wavelengths) so as to function asintended with the corresponding laser unit.

While current laser units allow for some tolerance (i.e., optical fiberdimensions, properties, or conditions may have some variation withoutsignificantly affecting functioning of the laser system), the range ofpermissible tolerance is exceedingly tight. For example, optical fibershave a very small diameter which is generally measured on the micronscale. The diameter of the optical fiber may impact the transmission oflaser radiation through the optical fiber and thus may impact the laserradiation emitted from the delivery tip of the optical fiber. As such,there is very little room for variation in the manufacture of opticalfibers. Manufacturing costs are increases as a result of the high degreeof precision required to make sure the diameter of an optical fiberfalls within the permissible tolerance. Furthermore, if a given opticalfiber falls outside of a permissible tolerance (i.e., the diameter istoo be or too small), use of the noncompliant optical fiber may resultin transmission of laser radiation that is not at the desiredwavelength. In turn, use of a noncompliant optical fiber runs the riskof providing an ineffective treatment and, in some instance, can causeadditional unintended damage and harm.

SUMMARY

The present invention provides a system for calibrating output from alaser source to compensate for increased variation in laser opticalfibers. In such a system, the elements generally include a laser sourcefor generating laser energy to be provided to one of a plurality oflaser probes couplable thereto. Each laser probe includes an opticalfiber, including a fiber optic core, adapted to direct laser radiationfrom the laser source, through the fiber, and to a desired the treatmentarea. The system further includes a laser management system for managingthe laser source. The management system includes a control systemconfigured to adjust laser energy output from the laser source to anygiven laser probe to maintain a consistent level of laser radiationdelivered to the target area, despite variation in the fiber optic coreof any given laser probe.

More specifically, as part of the initial setup, the control systemreceives data associated with a laser probe coupled to the laser source.The data may include one or more dimensions of the fiber optic core ofthe laser probe, including fiber optic core diameter. The data is thenanalyzed by the controller and, based on the analysis, a determinationof an optimum level of laser energy output from the laser source ismade. The optimum level of laser energy output from the laser source isbased on a correlation of the laser probe data, such as specificdimensions of the fiber optic core, with calibration data. Thecalibration data may generally include a plurality of sets of values,wherein each set of values may include a laser energy output level fromthe laser source, a diameter of a fiber optic core of a laser probe toreceive the laser energy output level, and the resulting wavelengthvalue of laser radiation emitted from the delivery tip of the laserprobe. In a preferred embodiment, the resulting wavelength value oflaser radiation to be emitted from the delivery tip remains constant,regardless of the diameter of the fiber optic core. In such anembodiment, the laser management system (i.e., the control system)automatically adjusts the laser energy output level from the lasersource (i.e., increases or decreases output level) for any givendiameter of a fiber optic core so as to maintain the emission of laserradiation upon a target area at a consistent wavelength, despitevariation in the diameter of fiber optic cores from the plurality oflaser probes.

Accordingly, the system of the present invention is able to compensatefor wide range of variations across a plurality of laser probes bysimply adjusting output of the laser source to account for suchvariations. In turn, the manufacture tolerance for optical fibersimproves as less precision is required during the manufacturing process,which reduces overall costs. Furthermore, by fine tuning of the laseroutput, the laser radiation is maintained at a consistent wavelength,ensuring that the target area is treated as intended and patient safetyis maintained.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 diagrams an excimer laser system of the present disclosure.

FIG. 2 diagrams the excimer laser system of the present disclosure and ameans for calibrating laser output to compensate for increased variationin optical fibers of laser probes. FIG. 3 diagrams a process ofcalibrating laser output, including adjustment of laser energy outputfrom the laser source to a laser probe to account for variation in thefiber optic core of the laser probe.

FIG. 4 shows an embodiment an excimer laser unit.

FIG. 5 shows an embodiment of a probe for use with the excimer lasersystem.

FIG. 6 shows a cross-sectional view of the probe taken along line A-A ofFIG. 5 .

FIG. 7 shows a cross-sectional view of the probe taken along line B-B ofFIG. 5 .

FIG. 8 shows an embodiment a laser probe attached to an excimer laserunit.

FIG. 9 shows an enlarged view of a connection between the laser probeand the excimer unit and delivery of an adjusted laser energy outputlevel to the laser probe based on calibration techniques.

DETAILED DESCRIPTION

The invention provides a system for calibrating output from a lasersource to compensate for increased variation in laser optical fibers. Insuch a system, the elements generally include a laser source forgenerating laser energy to be provided to one of a plurality of laserprobes couplable thereto. Each laser probe includes an optical fiber,including a fiber optic core, adapted to direct laser radiation from thelaser source, through the fiber, and to a desired the treatment area.The system further includes a laser management system for managing thelaser source. The management system includes a control system configuredto adjust laser energy output from the laser source to any given laserprobe to maintain a consistent level of laser radiation delivered to thetarget area, despite variation in the fiber optic core of any givenlaser probe.

Accordingly, the system of the present invention is able to compensatefor wide range of variations across a plurality of laser probes bysimply adjusting output of the laser source to account for suchvariations. In turn, the manufacture tolerance for optical fibersimproves as less precision is required during the manufacturing process,which reduces overall costs. Furthermore, by fine tuning of the laseroutput, the laser radiation is maintained at a consistent wavelength,ensuring that the target area is treated as intended and patient safetyis maintained.

The system of the present invention is particularly well suited forintraocular procedures in which laser treatment of target tissues isdesired. In particular, the laser source, laser management system, andlaser probes of the present invention are preferably used for treatingglaucoma and useful in performing a laser trabeculostomy. However, itshould be noted that the system consistent with the present disclosurecan be used in any laser treatment of various conditions, includingother eye conditions (i.e., diabetic eye diseases, such as proliferativediabetic retinopathy or macular oedema, cases of age-related maculardegeneration, retinal tears, and retinopathy of prematurity, andlaser-assisted in situ keratomileusis (LASIK) to correct refractiveerrors, such as short-sightedness (myopia) or astigmatism) as well asother conditions in general and other practice areas (non-ocularpractice areas).

FIG. 1 diagrams an excimer laser system, including a laser unit system100 and a laser probe 200 to be attached to the laser unit system 100.The system 100 includes a laser source 102, and a laser managementsystem 108. The laser probe 200 includes a fiber core 204. As will bedescribed in greater detail herein, many of the components of the laserunit system 100 may be contained in a housing, such as a moveableplatform, to be provided in a setting in which the procedure is to beperformed (e.g., operating room, procedure room, outpatient officesetting, etc.) and the probe 200 may connect to the housing for useduring treatment. Upon coupling the probe 200 to the housing, the fibercore 202 is coupled to the laser source 102 and adapted to direct laserradiation from the laser source 102, through the fiber, and to thetreatment area.

The laser source 102 includes an excimer laser 104 and a gas cartridge108 for providing the appropriate gas combination to the laser 104. Theexcimer laser 104 is a form of ultraviolet laser that generally operatesin the UV spectral region and generates nanosecond pulses. The excimergain medium (i.e., the medium contained within the gas cartridge 106) isgenerally a gas mixture containing a noble gas (e.g., argon, krypton, orxenon) and a reactive gas (e.g., fluorine or chlorine). Under theappropriate conditions of electrical stimulation and high pressure, apseudo-molecule called an excimer (or in the case of noble gas halides,exciplex) is created, which can only exist in an energized state and cangive rise to laser light in the UV range.

Laser action in an excimer molecule occurs because it has a bound(associative) excited state, but a repulsive (dissociative) groundstate. Noble gases such as xenon and krypton are highly inert and do notusually form chemical compounds. However, when in an excited state(induced by electrical discharge or high-energy electron beams), theycan form temporarily bound molecules with themselves (excimer) or withhalogens (exciplex) such as fluorine and chlorine. The excited compoundcan release its excess energy by undergoing spontaneous or stimulatedemission, resulting in a strongly repulsive ground state molecule whichvery quickly (on the order of a picosecond) dissociates back into twounbound atoms. This forms a population inversion. The excimer laser 104of the present system 100 is an XeCl excimer laser and emits awavelength of 308 nm.

The laser management system 108 manages the laser source 102. Inparticular, as shown in FIG. 2 , the laser management system 108includes a controller 110 (also referred to herein as a “control system110”). The controller 110 provides an operator (i.e., surgeon or othermedical professional) with control over the output of laser signals(from the laser source 102 to the fiber core 202) and, in turn, controlover the transmission of laser energy from the fiber core 202 of theprobe 200. However, prior to providing an operator with control overlaser output, the laser management system 108 provides a calibrationprocess in which laser energy output from the laser source 102 to thelaser probe 200 is calibrated to maintain a consistent level of laserradiation delivered from the probe 200 to the target area, despite anyvariation in the fiber optic core 202 of the probe 200.

FIG. 2 diagrams the laser unit system 100 and calibration of laseroutput to a laser probe 200 to be used with the system 100 to accountfor variation in the fiber optic core of the laser probe 200. FIG. 3diagrams a process of calibrating laser output, including adjustment oflaser energy output from the laser source to a laser probe to accountfor variation in the fiber optic core 202 of the laser probe 200.

As part of the initial setup, the controller 110 receives dataassociated with a laser probe coupled to the laser source 102. In thisinstance, data from laser probe 200 is provided to the controller 110.This data may be manually entered (via a user interface provided on thesystem 100) or may be automatically read from readable device or labelon the probe 200 via an associated reader of the system 100. The datamay include physical characteristics of the probe 200, including, butnot limited to, physical dimensions of the fiber optic core 202, one ormore measured values or physical properties of the fiber optic core 202,and physical dimensions and/or measured values or physical properties ofother components of the probe 200. In one embodiment, the data includesa diameter of the fiber optic core 202.

The data is then analyzed by the controller 110 and, based on theanalysis, a determination of an optimum level of laser energy outputfrom the laser source 102 is made. The analysis is based on acorrelation of the laser probe data, such as specific dimensions of thefiber optic core, with calibration data. The calibration data is storedin a database, either a local database (i.e., calibration database 112)forming part of the laser unit system 100, or a remote database hostedvia a remote server 300 (i.e., calibration database 302). For example,in some embodiments, the system 100 may communicate and exchange datawith a remote server 300 over a network. The network may represent, forexample, a private or non-private local area network (LAN), personalarea network (PAN), storage area network (SAN), backbone network, globalarea network (GAN), wide area network (WAN), or collection of any suchcomputer networks such as an intranet, extranet or the Internet (i.e., aglobal system of interconnected network upon which various applicationsor service run including, for example, the World Wide Web).

The calibration data may generally include a plurality of sets ofvalues, wherein each set of values may include a laser energy outputlevel from the laser source, a diameter of a fiber optic core of a laserprobe to receive the laser energy output level, and the resultingwavelength value of laser radiation emitted from the delivery tip of thelaser probe. In a preferred embodiment, the resulting wavelength valueof laser radiation to be emitted from the delivery tip remains constant,regardless of the diameter of the fiber optic core. In such anembodiment, the laser management system (i.e., the control system)automatically adjusts the laser energy output level from the lasersource (i.e., increases or decreases output level) for any givendiameter of a fiber optic core so as to maintain the emission of laserradiation upon a target area at a consistent wavelength, despitevariation in the diameter of fiber optic cores from the plurality oflaser probes.

The controller 110 may include software, firmware and/or circuitryconfigured to perform any of the aforementioned operations. Software maybe embodied as a software package, code, instructions, instruction setsand/or data recorded on non-transitory computer readable storage medium.Firmware may be embodied as code, instructions or instruction setsand/or data that are hard-coded (e.g., nonvolatile) in memory devices.“Circuitry”, as used in any embodiment herein, may comprise, forexample, singly or in any combination, hardwired circuitry, programmablecircuitry such as computer processors comprising one or more individualinstruction processing cores, state machine circuitry, and/or firmwarethat stores instructions executed by programmable circuitry. Forexample, the controller 104 may include a hardware processor coupled tonon-transitory, computer-readable memory containing instructionsexecutable by the processor to cause the controller to carry out variousfunctions of the laser system 100 as described herein, including thecalibration process. For example, the controller 110 may include custom,proprietary, known and/or after-developed statistical analysis code (orinstruction sets), hardware, and/or firmware that are generallywell-defined and operable to receive two or more sets of data andidentify, at least to a certain extent, a level of correlation andthereby associate the sets of data with one another based on the levelof correlation.

FIG. 4 shows an embodiment an excimer laser unit 100 provided in aninstrument 400. As previously described, one or more components of thesystem 100 can be contained within the instrument 400. In the presentembodiment, the laser source 102 (including the excimer laser 104 andgas cartridge 106) and laser management system 108, including thecontroller 110, are contained within a housing 402. The housing 402 haswheels 404 and is portable. The instrument 400 further includes apush-pull handle 405 which assists with portability of the instrument400. The instrument 400 further includes a connection port 406 forreceiving a connecting end of the laser probe 200 to establish aconnection between the fiber core 202 and the laser source 102. Theinstrument 400 further includes various inputs for the operator, such asa fiber probe cap holder 408, an emergency stop button 410, and a powerswitch 412. The instrument 400 further includes a foot pedal 414extending from the housing 402 and is operable to provide control overthe delivery of shots from the excimer laser 104 to the fiber core 202of the probe 200. The instrument 400 further includes a display 416,which may be in the form of an interactive user interface. In someexamples, the interactive user interface displays patient information,machine settings, and procedure information. As previously described, anoperator may manually input the laser probe data via the interactiveuser interface to thereby provide such data to the laser managementsystem 108 and controller 110. However, in some embodiments, the datamay be automatically read from a readable device or label on the probe200 via an associated reader of the system 100.

FIG. 5 shows an embodiment of a probe 500 for use with the excimer lasersystem 100. The probe 500 is a single use, disposable unit. The probe500 generally includes a fiber core coupled to the laser source 102 byway of a connector 502 (elongated cord) extending from the body of theprobe 500 and having a connection assembly 504 configured to be receivedwithin the connection port 406 of the instrument 400. The probe 500further includes a delivery tip 506 from which laser energy (from thefiber core) may be emitted. The probe 500 includes a handheld body 508,which may include a finger grip 510 with ridges or depressions 512. Thebody 508 of the handheld probe 500 may be metal or plastic.

FIGS. 6 and 7 show cross-sectional views of the probe 500 taken alongline A-A and line B-B of FIG. 5 , respectively. As shown, a fiber opticcore 518 runs through the probe 500 and forms part of the connector 502.A protective sheath 516 surrounds the fiber optic core 518. In someexamples, the protective sheath 516 is a protective plastic or rubbersheath. The fiber optic core 518 further form part of the delivery tip506 of the probe 500. A metal jacket 520 surrounds the fiber optic core518 and optical fiber 520. In some instances, a stainless steel jacket520 surrounds and protects the fiber optic core 518.

FIG. 8 shows an embodiment a laser probe 500 attached to a laser unitsystem 100. As previously described, upon attachment of the laser probe500 to the system 100 (i.e., coupling between the connection assembly504 of the probe 500 and connection port 406 of the system 400), thelaser management system 108 (including the controller 110) performcalibration processes prior to use of the probe 500. In particular, dataassociated with characteristics of the probe 500, such as the diameterof the fiber optic core, is provided to the laser management system 108.The data is then analyzed by the controller 110 and, based on theanalysis, a determination of an optimum level of laser energy outputfrom the laser source is made. FIG. 9 shows an enlarged view of aconnection between the laser probe 500 and the system 100 and deliveryof an adjusted laser energy output level to the laser probe based oncalibration techniques. The optimum level of laser energy output fromthe laser source is based on a correlation of the laser probe data, suchas specific dimensions of the fiber optic core, with calibration data.The controller 110 automatically adjusts the laser energy output levelfrom the laser source (i.e., increases or decreases output level) forany given diameter of a fiber optic core so as to maintain the emissionof laser radiation upon a target area at a consistent wavelength,despite variation in the diameter of fiber optic cores from theplurality of laser probes.

Accordingly, the system of the present invention is able to compensatefor wide range of variations across a plurality of laser probes bysimply adjusting output of the laser source to account for suchvariations. In turn, the manufacture tolerance for optical fibersimproves as less precision is required during the manufacturing process,which reduces overall costs. Furthermore, by fine tuning of the laseroutput, the laser radiation is maintained at a consistent wavelength,ensuring that the target area is treated as intended and patient safetyis maintained.

As used in any embodiment herein, the term “module” may refer tosoftware, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices. “Circuitry”, as usedin any embodiment herein, may comprise, for example, singly or in anycombination, hardwired circuitry, programmable circuitry such ascomputer processors comprising one or more individual instructionprocessing cores, state machine circuitry, and/or firmware that storesinstructions executed by programmable circuitry. The modules may,collectively or individually, be embodied as circuitry that forms partof a larger system, for example, an integrated circuit (IC), systemon-chip (SoC), desktop computers, laptop computers, tablet computers,servers, smart phones, etc.

Any of the operations described herein may be implemented in a systemthat includes one or more storage mediums having stored thereon,individually or in combination, instructions that when executed by oneor more processors perform the methods. Here, the processor may include,for example, a server CPU, a mobile device CPU, and/or otherprogrammable circuitry.

Also, it is intended that operations described herein may be distributedacross a plurality of physical devices, such as processing structures atmore than one different physical location. The storage medium mayinclude any type of tangible medium, for example, any type of diskincluding hard disks, floppy disks, optical disks, compact diskread-only memories (CD-ROMs), compact disk rewritables (CD-RWs), andmagneto-optical disks, semiconductor devices such as read-only memories(ROMs), random access memories (RAMs) such as dynamic and static RAMs,erasable programmable read-only memories (EPROMs), electrically erasableprogrammable read-only memories (EEPROMs), flash memories, Solid StateDisks (SSDs), magnetic or optical cards, or any type of media suitablefor storing electronic instructions. Other embodiments may beimplemented as software modules executed by a programmable controldevice. The storage medium may be non-transitory.

As described herein, various embodiments may be implemented usinghardware elements, software elements, or any combination thereof.Examples of hardware elements may include processors, microprocessors,circuits, circuit elements (e.g., transistors, resistors, capacitors,inductors, and so forth), integrated circuits, application specificintegrated circuits (ASIC), programmable logic devices (PLD), digitalsignal processors (DSP), field programmable gate array (FPGA), logicgates, registers, semiconductor device, chips, microchips, chip sets,and so forth.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments.

The term “non-transitory” is to be understood to remove only propagatingtransitory signals per se from the claim scope and does not relinquishrights to all standard computer-readable media that are not onlypropagating transitory signals per se. Stated another way, the meaningof the term “non-transitory computer-readable medium” and“non-transitory computer-readable storage medium” should be construed toexclude only those types of transitory computer-readable media whichwere found in In Re Nuijten to fall outside the scope of patentablesubject matter under 35 U.S.C. § 101.

The terms and expressions which have been employed herein are used asterms of description and not of limitation, and there is no intention,in the use of such terms and expressions, of excluding any equivalentsof the features shown and described (or portions thereof), and it isrecognized that various modifications are possible within the scope ofthe claims. Accordingly, the claims are intended to cover all suchequivalents.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

Various modifications of the invention and many further embodimentsthereof, in addition to those shown and described herein, will becomeapparent to those skilled in the art from the full contents of thisdocument, including references to the scientific and patent literaturecited herein. The subject matter herein contains important information,exemplification and guidance that can be adapted to the practice of thisinvention in its various embodiments and equivalents thereof.

1-22. (canceled)
 23. A method for performing intraocular procedures fortreating eye conditions, said method comprising: connecting a firstprobe of a plurality of excimer laser probes to an excimer laser source,wherein: the excimer laser source is configured to generate laser energyto be provided to each of the plurality of excimer laser probes, and theplurality of excimer laser probes are single use and disposable, suchthat the plurality of excimer laser probes are each coupleable, one at atime, to said excimer laser source; receiving, by a processor incommunication with the excimer laser source after the first probe isconnected to the excimer laser source, first data from the first probe,wherein the first data is indicative of at least a first diameter of afirst fiber optic core of the first probe; determining, by theprocessor, a first laser energy output level to transmit to the firstprobe; receiving, by the processor, a first signal indicative of a usercontrol of the excimer laser source; transmitting, by the processor inresponse to receiving the first signal, a second signal indicative ofthe first laser energy output level to the excimer laser source, whereinthe first laser energy output level is configured to cause the firstprobe to emit first energy from the excimer laser at a first desiredlevel; disconnecting the first probe from the excimer laser source;connecting a second probe of the plurality of excimer laser probes tothe excimer laser source after the first probe is disconnected;receiving, by the processor after the second probe is connected to theexcimer laser source, second data from the second probe, wherein secondfirst data is indicative of at least a second diameter of a second fiberoptic core of the second probe; determining, by the processor, a secondlaser energy output level to transmit to the second probe; receiving, bythe processor, a third signal indicative of the user control of theexcimer laser source; and transmitting, by the processor in response toreceiving the second signal, a fourth signal indicative of the secondlaser energy output level to the excimer laser source, wherein thesecond laser energy output level is configured to cause the second probeto emit second energy from the excimer laser at a second desired level.24. (canceled)